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TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus

Uremic Pruritus Clinical Trial

Official title:
A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus

Clinical Trial Summary

This study is a 2-part study.

Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.

Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03002233
Study type Interventional
Source Toray Industries, Inc
Contact
Status Completed
Phase Phase 1
Start date November 2016
Completion date July 2017
View Details
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